Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06143358
• Other study ID #: SY-1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: July 7, 2023

Study information

• Verified date: November 2023
• Source: Beijing University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Through the clinical observation of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease (phlegm-heat lung syndrome), (1) to evaluate the safety of Qingcheng Pingxian Granules in the acute exacerbation of chronic obstructive pulmonary disease; (2) to observe the clinical efficacy of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease, to provide an effective medication and solution for the treatment of acute exacerbation of chronic obstructive pulmonary disease, and to provide data for the development of the further application of Qingcheng Pingxian Granules.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Meet the diagnostic criteria of AECOPD.

2. Chinese medicine diagnosis is consistent with phlegm-heat and lung depletion evidence

3. 40 years old = age = 90 years old

4. Patients who signed the informed consent form and volunteered to participate in the study

Exclusion Criteria:

1. Combined with other primary lung diseases such as bronchial asthma, bronchiectasis, etc.

2. Combination of serious cardiovascular, urinary, digestive, haematopoietic, endocrine metabolic system diseases, other psychiatric and neurological diseases.

3. Pregnant or lactating patients.

4. Allergic to the clinical trial drugs.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Qingkepingchuan Granules
Qingkepingchuan Granules,Take it three times a day with water after meals.

Other:
• conventional treatment
Oxygen intake, selection of appropriate antibiotics based on lab results, and other treatments

Locations

Country	Name	City	State
China	Beijing University of Chinese Medicine	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Zhang Zhijie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chinese Medicine Symptoms Scale	Record changes in patients' TCM indicators?The scale includes cough, wheezing, shortness of breath, sputum volume, chest tightness, sputum colour, sputum quality, fever, thirst, irritability, constipation, tongue coating, and pulse. The first four items are rated 0-6, and the last nine items are rated 0-3, with higher ratings indicating poorer treatment outcomes.	Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
Primary	COPD assessment test	Record changes in the patient's condition	Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
Primary	breathlessness measurement using the modified British Medical Research Council	Record changes in the patient's condition	Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
Secondary	6-minute walking test	Record changes in the patient's condition	Before the start of treatment, 2 weeks of treatment